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Added 1 min ago
IT SPECIALIST (INFOSEC)
U.S. Air Force - Agency Wide
Peterson AFB, CO
…technical knowledge of interrelated IT specialties sufficient to lead and facilitate discussions and negotiations among interagency program partners to conduct mutually beneficial,…
Added 1 min ago
Electrical Engineer II
Honeywell Technologies
Arvada, CO
As an Electrical Engineer II here at Honeywell, you will contribute to the design, development, and implementation of electrical systems and components specifically tailored for process…
Added 1 min ago
Electrical/Test Engineer II
Lockheed Martin
Littleton, CO
Capability to lead a team responsible for development and test of integrate test systems, and experience as Subject Matter Engineer or equivalent.
Added 1 min ago
Circuit Design Engineering Associate Manager, Avionics, Secret Clearance
Lockheed Martin
Littleton, CO
As a Circuit Design Engineering Associate Manager , you will lead the development of Avionics Packages for the Initiation and Preset Subsystem for the D5LE2 Trident II Submarine Launched…
Added 1 min ago
Network Engineer - Sr. Staff
Lockheed Martin
Colorado Springs, CO
The Network Communications Engineer will design, configure, secure, monitor, and troubleshoot complex, high-performance communication networks supporting mission-critical systems.
Added 2 mins ago
DevOps Engineer III
Deloitte
Denver, CO
Contributing to project deliverables, technical documentation, environment standards, and implementation plans while supporting client-facing discussions and delivery milestones
Added 2 mins ago
2027 Sophomore Internship Program - Software Engineer Intern, Highlands Ranch
Visa USA Inc
Denver, CO
Added 2 mins ago
Building Mechanical Engineer
Jacobs
Colorado Springs, CO · Denver, CO
Lead meetings and communicate with clients, vendors, and other project stakeholders to establish project needs and discuss design issues.
Added 2 mins ago
Intermediate Environmental, Health & Safety (EHS) Auditor
Jacobs
Denver, CO
Certified Safety Professional (CSP), CIH, Professional Engineer (PE) or Project Management Professional (PMP), or similar credentials
Added 2 mins ago
Supplier Support Manufacturing Engineer
GE Aerospace
Denver, CO · Longmont, CO · Lafayette, CO
The Supplier Support Manufacturing Engineer is responsible for addressing part shortages and ensuring supplier performance aligns with Clear to Build (CTB) targets. This role emphasizes…
Added 2 mins ago
GA
Sr Staff Applications Operations Engineer – Engineering Tools Automation & AI Ops
GE Aerospace
Denver, CO · Lafayette, CO · Longmont, CO
- $131,000 to $174,000 USD / year
…application pods (software, hardware and electronic design, and project and portfolio management tools) for US and UK…
Added 2 mins ago
Transmission Line Engineer I, II, III, or Senior
Tri-State Generation and Transmission Association, Inc.
Westminster, CO
There is one position available and the position will be filled at one of four job grade levels: Transmission Line Engineer I, job grade 7; Transmission Line Engineer II, job grade 8,…
Added 4 mins ago
Civil Project Manager - PE
GPAC
Austin, TX
Our client, a reputable and growing civil engineering firm, is seeking an experienced Professional Engineer (PE) to join its team in a Project Manager capacity. This individual will play a…
Added 5 mins ago
Senior Civil Engineer - PE (Water/Wastewater or Transportation)
GPAC
San Antonio, TX
Our client, a reputable and growing civil engineering firm, is seeking a Senior Professional Engineer (PE) to join its Infrastructure team. This individual will play a key role in leading…
Added 16 mins ago
Project Manager
GPAC
Riverside, CA
Our client, a reputable and growing multi-disciplinary design firm in Riverside, CA, is seeking an experienced Project Manager. This individual will lead projects across architecture,…
Added 17 mins ago
Civil Project Engineer
GPAC
Riverside, CA
Our client, a reputable and growing multi-disciplinary design firm in Riverside, CA, is seeking a senior Civil Project Engineer. This individual will serve as the senior licensed…
Added 35 mins ago
Project Manager
GPAC
Milwaukee, WI
Lead all aspects of project management from award through completion
Added 35 mins ago
KS
Associate Sales Representative
Kastle Systems
Falls Church, VA
- $36 to $38 USD / hour
…that the most effective approach is a complete one: because we engineer, install, monitor, and maintain your system, we are invested in its end-to-end performance. Learn more about who we…
Added 39 mins ago
G
Manufacturing Engineer
GPAC
Gainesville, GA
- $80,000 to $100,000 USD / year
The Manufacturing Engineer will play a lead role in implementing and sustaining lean manufacturing principles, identifying opportunities for process improvement, and supporting the…
Added 39 mins ago
G
Manufacturing Engineer
GPAC
Torrington, CT
- $80,000 to $100,000 USD / year
The Manufacturing Engineer will play a lead role in implementing and sustaining lean manufacturing principles, identifying opportunities for process improvement, and supporting the…
Added 41 mins ago
G
Manufacturing Manager
GPAC
Westford, MA
- $100,000 to $125,000 USD / year
The Manufacturing Engineer will play a lead role in implementing and sustaining lean manufacturing principles, identifying opportunities for process improvement, and supporting the…
Added 41 mins ago
G
Manufacturing Engineer
GPAC
Rochester, NY
- $80,000 to $100,000 USD / year
The Manufacturing Engineer will play a lead role in implementing and sustaining lean manufacturing principles, identifying opportunities for process improvement, and supporting the…
Added 48 mins ago
ST
Associate Director, Corporate Strategy
Sarepta Therapeutics, Inc.
Cambridge, MA
- $160,800 to $201,000 USD / year
Scope workstreams: Collaborate with project lead to propose goals, scope, workstreams, analytical approach, success measures, required stakeholders, and roles and responsibilities for part…
Added 50 mins ago
O
Senior Director, Special Projects - Data Center Operations (Nashville, TN)
Oracle
Jefferson City, MO
- $193,600 to $414,400 USD / year
You will lead directors, managers, technical SMEs, project managers, vendors, and cross-functional partners across Construction, Engineering, Commissioning, Data Center Operations,…
Added 1 hour ago
Staff Engineer – Mechanical Analysis
GE Aerospace
Evendale, OH
…ability to analyze and resolve problems. Demonstrated ability to lead programs / projects. Ability to document, plan, market, and execute programs. Established project management…

Werfen

Quality Engineer III

San Diego, CA, United States

$100,000 to $125,000 USD / year

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Job details

Pay: $100,000 to $125,000 USD / year
Apply by: Nov 3, 2027
Posting language: English
Posted: Nov 3, 2024

Original job description

Introduction

Werfen

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We’re passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

Position Summary:

The Quality Engineer III creates various quality system documents including procedures and work instructions. Quality Engineer III will support a wide range of quality-related engineering activities including, but not limited to, process development, product development, risk management, root cause investigation, risk assessments and verification/validation. The Quality Engineer III, Quality will support and/or lead continuous improvement projects and will be a key resource for the organization in the proper use of statistics including capability studies, gage R&R, test method validation and acceptance sampling plans.

The annual base salary range for this role is currently $100,000 to $125,000. This is a bonus-eligible position. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave.

Responsibilities

Key Accountabilities:

Write, review, and approve quality system documents which comply with applicable regulations and standards.
Participate and/or lead process validation teams.
Work cross-functionally, as a key resource, to solve problems related to product or process quality issues; investigate non-conformances, identify root cause, and determine/implement appropriate corrective action plans.
Support design control project teams: ensure predetermined requirements are met and that compliance is maintained.
Participate in internal and external audits.
Conduct risk and trend evaluations for product non-conformances.
May prepare technical microbiology and sterility assurance reports and formulate microbiology or sterility assurance recommendations for disposition or other actions related to product non-conformances.
Works with manufacturing, R&D, Service, Distribution, Sales & Marketing, and others outside the company (as needed) to recommend or prepare corrective / preventive actions (CAPA).
Reviews and approves change orders for product performance, process changes, labeling and marketing communications as required.
Interprets regulations and procedures to ensure documents are sound and defensible to auditors and regulatory bodies. Supports internal and external audits.
Ability to prioritize urgent matters.

Networking/Key relationships:

Manufacturing/Operations
Manufacturing Engineering
Regulatory Affairs
Research & Development
Service

Qualifications

Minimum Knowledge & Experience Required for the Position:

Bachelor’s degree, or equivalent, plus a minimum of (3) to five to (5) year previous experience, preferably within a regulated medical device or pharmaceutical environment
Knowledge of Risk Management discipline and must be able to apply quality principles (GMPs, EN ISO 14971:2012,) to the R&D environment
ASQ certification and/or Six Sigma Green/Black belt preferred
Broad knowledge of quality engineering principles required
Broad knowledge of Quality System Regulations required
Previous experience with statistical sampling and analysis, design of experiments (DOE) and validation required
Good technical writing skills required
Good communication and presentation skills
Knowledge of Microsoft Office required; knowledge of statistical software, and experience with large enterprise resource planning (ERP) system required
Demonstrated good problem solving skills required
Strong planning and organizational skills required
Expertise in Gamma Sterilization a plus
Ability to lead cross functional projects to timely and effective conclusion
Ability to collaborate internally and externally; working with vendors and subcontractors; and consultants with no supervision
Understands and demonstrates aseptic technique.
Experience with GLP principles.

Closing

If you are interested in constantly learning and being challenged on a daily basis we encourage you to submit your resume or CV.

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact NAtalentacquisition@werfen.com for assistance.

We operate directly in over 30 countries, and in more than 100 territories through distributors. Annual revenue is approximately $2 billion and more than 7,000 employees around the world comprise our Werfen team.

www.werfen.com

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